Condition category
Digestive System
Date applied
25/04/2008
Date assigned
01/05/2008
Last edited
09/10/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Chien-Chang Chen

ORCID ID

Contact details

5
Fu-Hsing Street
Kwei-Shan
Taoyuan
333
Taiwan

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00463190

Protocol/serial number

N/A

Study information

Scientific title

Effect of probiotics (Bio-Three®) in children's enterocolitis

Acronym

Study hypothesis

Probiotics have been shown to be effective in the treatment of these conditions. There are many mechanisms by which probiotics enhance intestinal health, including stimulation of immunity, competition for limited nutrients, inhibition of epithelial and mucosal adherence, inhibition of epithelial invasion and production of antimicrobial substances.

Hypothesis:
Probiotics medication (Bio-Three®) could inhibit gastrointestinal infection and reduce its inflammatory response in the intestine. We plan to explore the bacterial count (microbiology) and subsequent immune response in probiotic inhibition of enterocolitis in children.

Ethics approval

Institutional Review Board of Chang Gung Memorial Hospital, Taoyuan, Taiwan. Date of approval: 10/01/2006

Study design

Randomised, double-blind (subject, caregiver, investigator), placebo-controlled, parallel-assignment, safety/efficacy, single-centre study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Enterocolitis

Intervention

Treatment group: Oral probiotics (Bio-Three®) 3 times daily for 7 days
Control group: Placebo 3 times daily for 7 days

Bio-three® contains a mixture of Bacillus mesentericus, Streptococcus faecalis and Clostridium butyricium. Total bacterial count: 1.5 x 10^8 colony forming units (cfu) per tablet.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

To determine whether probiotics medication Bio-Three® inhibits gastrointestinal infection and reduce its inflammatory response in the intestine. The following were assessed:
1. Clinical symptoms 2 days after medication
2. Microbiology study 3 days and one week after medication

The time and the consistency of every stool were recorded and the total hospital duration was calculated.

Severity of diarrhoea was evaluated according to the following parameters: number of stools, fecal consistency, the presence or absence of mucus, and blood in stools.

Secondary outcome measures

Other clinical symptoms/signs including fever, vomiting, dehydration, abdominal pain, bloating, daily dietary intake and appetite were also recorded for 7 to 10 days.

Overall trial start date

01/02/2006

Overall trial end date

30/11/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age: From 3 months to 12 years, both male and female children
2. Clinical symptom of diarrhoea less than 3 days

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

300

Participant exclusion criteria

1. Severe abdominal distension with risk of bowel perforation
2. Risk of sepsis
3. Past history of surgical operation of gastrointestinal tracts

Recruitment start date

01/02/2006

Recruitment end date

30/11/2007

Locations

Countries of recruitment

Taiwan

Trial participating centre

5, Fu-Hsing Street
Taoyuan
333
Taiwan

Sponsor information

Organisation

Maywufa Company Ltd (Taiwan)

Sponsor details

5F
167
Fu-Hsing North Road
Taipei
105
Taiwan

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

Chang Gung Memorial Hospital (Taiwan)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Maywufa Company Ltd (Taiwan)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes